| FDA
UDI Rule Overview
On September 27, 2007, President George
W. Bush signed into law FDAAA (Public Law 110-85).
Section 226 of FDAAA amended the Federal Food, Drug,
and Cosmetic Act (the act) by requiring the establishment
of a UDI system. Specifically, section 226(a) of
FDAAA created a new section 519(f) of the act (21
U.S.C. 360i(f)) stating that:
"The Secretary shall promulgate
regulations establishing a unique device identification
system for medical devices requiring the label of
devices to bear a unique identifier, unless the
Secretary requires an alternative placement or provides
an exception for a particular device or type of
device. The unique identifier shall adequately identify
the device through distribution and use, and may
include information on the lot or serial number."
A UDI system will provide for early detection
of defective devices and will facilitate device
recalls to ultimately enhance patient safety and
reduce medical errors. FDAAA directs FDA to implement
the UDI system through the formal rulemaking process.
As part of this process, FDA held a public workshop
on February 12, 2009 where the following was discussed:
- developing standardized UDIs
- determining placement and technology of UDIs
- creation and maintenance of a UDI database
- implementation/adoption of UDIs by relevant
stakeholders
Additionally, FDA sought industry input regarding
what information to include in a UDI, which devices
to exempt from the requirement, and how to address
reprocessed, single-use devices. FDA intends to
issue a proposed rule on the UDI system by the end
of 2009 with the Final Rule slated to be released
in 2010.
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